Human Genome Sciences, Inc. (HGS) has submitted a BLA to the FDA for approval to market Benlysta (belimumab) for the treatment of systemic lupus erythematosus (SLE).

The BLA submission includes the results from two Phase III trials involving 1,684 patients with autoantibody-positive SLE. In the studies, belimumab 10 mg/kg plus standard of care achieved a statistically significant improvement in patient response rate as measured by the SLE Responder Index at Week 52, compared with placebo plus standard of care. Results also showed that belimumab was generally well tolerated.

“We and GlaxoSmithKline have now submitted regulatory applications for Benlysta in both the U.S. and Europe,” said H. Thomas Watkins, president and chief executive officer, HGS. “Our companies will continue to work together to achieve licensure and bring this potentially important new therapeutic option to market. Based on the results of our pivotal Phase III studies, HGS believes Benlysta could become the first new approved drug for systemic lupus in more than 50 years.”

Belimumab is being developed with GSK under a 2006 co-development and commercialization agreement. GSK submitted a Marketing Authorization Application for belimumab to the European Medicines Agency (EMA) on June 4, 2010.